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BE Study Between a Capsule and a Sachet Formulation of D961H by Pharmacodynamics in Japanese Healthy Male Subjects

NCT01964131 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2013-12-31

No results posted yet for this study

Summary

The purpose of this study is; To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH\>4.

To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH\>3 during 24 hours and 24-hour median pH.

To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.

To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.

Conditions

  • Gastric Ulcer
  • Duodenal Ulcer
  • Anastomotic Ulcer
  • Reflux Esophagitis
  • Etc.

Interventions

DRUG

D961H sachet 20 mg

Each subject will be randomised evenly to one of "Treatment: A--\>B (Sequence 1)" or "Treatment: B--\>A (Sequence 2)". Treatment A: D961H sachet 20 mg Treatment B: D961H HPMC capsule 20 mg

DRUG

D961H HPMC capsule 20 mg

Each subject will be randomised evenly to one of "Treatment: A--\>B (Sequence 1)" or "Treatment: B--\>A (Sequence 2)". Treatment A: D961H sachet 20 mg Treatment B: D961H HPMC capsule 20 mg

Sponsors & Collaborators

Principal Investigators

  • Megumi Inoue, MD, PhD · Hakata Clinic Medical Co. LTA

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01964131 on ClinicalTrials.gov